首页|基于温控IOT云平台冷链监管追溯体系的构建及应用:以人血白蛋白为例

基于温控IOT云平台冷链监管追溯体系的构建及应用:以人血白蛋白为例

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稳定的生物学性质是人血白蛋白等生物制品发挥正常临床生理功效以及避免或降低不良反应的重要保证,温度是影响其生物学性质的一个重要因素。目前,人血白蛋白等生物制品运输全过程温度记录以及产品的电子溯源体系这两方面信息化水平还处于起步阶段,不能实现全链条无缝温度监控。本研究以人血白蛋白为实例,建立了基于温控IOT云平台的冷链追溯系统并进行应用,可为生物制品的全过程冷链监管追溯以及医药冷链行业发展提供参考。
The Construction and Application of Cold Chain Supervision and Traceability System Based on Temperature Control IOT Cloud Platform:Taking Human Blood Albumin as an Example
Stable biological properties are an important guarantee for human blood albumin and other biological products to play a normal clinical physiological effect and avoid or reduce adverse reactions,and temperature is an important factor affecting their biological properties. At present,the informatization level of temperature recording in the whole process of transportation of biological products such as human blood albumin and electronic traceability system of products is still in its infancy,and seamless temperature monitoring of the whole chain cannot be achieved. This paper takes human blood albumin as an example to establish the research and application of cold chain traceability system based on temperature control IOT cloud platform,which can provide reference for the whole process of cold chain supervision and traceability of biological products and the development of pharmaceutical cold chain industry.

Human blood albuminBiological productsTemperature control IOT cloud platformCold chain supervision traceability system

刘绪平、肖小武、陈文强、陈秀良、易路遥

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江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌 330029

江西省药品认证审评中心,江西南昌 330006

江西国科美信医疗科技有限公司,江西抚州 344099

博雅生物制药集团股份有限公司,江西抚州 344100

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人血白蛋白 生物制品 温控IOT云平台 冷链监管追溯系统

2024

药品评价
江西省药学会

药品评价

影响因子:0.672
ISSN:1672-2809
年,卷(期):2024.21(8)